From: Shuger, Jill (HRSA) [mailto:[log in to unmask]]
Sent: Monday, February 25, 2013 1:51 PM
Subject: FW: NIH-NICHD-CDBPM-2013-13, Sources Sought: Pilot Newborn Screening Studies of Novel Technologies in a High Throughput Environment

Solicitation Number:
NIH-NICHD-CDBPM-2013-13
Notice Type:
Synopsis:
Added: Feb 21, 2013 4:26 pm
Pilot Newborn Screening Studies of Novel Technologies in a High Throughput Environment
Background:

The goal of newborn screening is to detect potentially fatal or disabling conditions in newborns, thereby providing a window of opportunity for early treatment, often while the child is still asymptomatic. Such early detection and treatment can have a profound impact on the clinical severity of the condition in the affected child. If left undiagnosed and untreated, the consequences of the targeted disorders can be dire, many causing irreversible neurological damage, intellectual, developmental and physical disabilities, and even death. In 2006, the American College of Medical Genetics (ACMG) developed newborn screening guidelines that recommend that all newborn infants be screened for 29 "core conditions" and that 25 secondary conditions identified during the core evaluations be reported. These recommendations have been accepted by the HHS Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) (authorized by the Children's Health Act of 2000), and by the Secretary of HHS. Most states now use this or very similar panels for newborn screening. Currently, there are thousands of rare disorders that have been identified and hundreds that could potentially benefit from newborn screening.

Sec. 116 of the Newborn Screening Saves Lives Act of 2007 encourages the NIH to "continue carrying out, coordinating, and expanding research in newborn screening --- including identifying, developing, and testing the most promising new screening technologies, in order to improve already existing screening tests, increasing the specificity of newborn screening, and expanding the number of conditions for which screening tests are available."

It has become evident that a major impediment to implementing new technologies in high throughput newborn screening laboratories is the ability to provide evidence of the feasibility of the assay, both scientifically and logistically, in a timely manner. This is especially apparent when screening for rare diseases where the likelihood of detecting cases during standard newborn screening in a single laboratory is low. Collaborative efforts, implemented across multiple states or newborn screening laboratories, are necessary for the successful development and implementation of new assays.

The purpose of this initiative is to establish a resource to be used to support the development of novel technologies in newborn screening by providing access to a pool of high throughput newborn screening laboratories (state or private) with the capacity to screen a large number of newborns in relatively short periods of time (12-18 months).

It is the intent of this initiative to encourage collaboration with other Federal agencies with each agency focusing on their areas of expertise in the field. The project will also leverage resources that are part of NICHD's Newborn Screening Translational Research Network (NBSTRN) including access to the Laboratory Performance Program developed to collect, aggregate and analyze de-identified screening data.

Requirements:

To be deemed capable of being included in the pool, the offeror must submit a written capability statement that clearly demonstrates their experience and ability to provide the following capabilities:

* Technical expertise and large-scale capacity to test for NICHD in identified newborn dried blood spots using appropriate screening technology either immediately or with a short set up period (less than3 months).

* Ability to provide efficient confirmatory testing procedures for presumed positive results.

* The capacity and resources needed for tracking positive cases and arranging for appropriate follow up care and referral of identified newborns who have screened positive for pilot disorders care in a timely manner.

* An administrative structure that is conducive to prospective, rather than retrospective, pilot testing (including documentation of ability to obtain human subjects approval within 6 months of being presented with an NICHD nominated condition).

* Adequate quality assurance and quality control procedures in place for accurate assessment of findings.

AT THIS TIME THE NICHD IS REQUESTING CAPABILITY STATEMENTS FROM ALL QUALIFIED BUSINESSES. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSAL. The applicable North American Industry Classification System (NAICS) code for this requirement is 541711.

All qualified businesses who believe that they have the capabilities described above are encouraged to submit two copies of a written capability statement to attention of Katharine Minker, Contracting Officer, at the address provided by 3:00 PM local time on March 15, 2013. The address where capability statements should be mailed to is: NIH, NICHD Office of Acquisitions, 6100 Executive Blvd., Room 7A-07 MSC 7510, Bethesda, Maryland 20892-7510. The Capability Statement should be limited to no more than 15 pages and it should clearly address each of the competencies stated above.

NO COLLECT CALL WILL BE ACCEPTED. RESPONDENTS MAY SUBMIT THEIR CAPABILITY STATEMENTS VIA E-MAIL. SEE NUMBERED NOTE 25.
Contracting Office Address:
Contracts Management Branch
6100 Executive Blvd., Suite 7A07, MSC7510
Bethesda, Maryland 20892-7510
Primary Point of Contact.:
Katharine Minker,
Contracting Officer
[log in to unmask]<mailto:[log in to unmask]>
Phone: 301-402-7571
Fax: 301-402-3676
Secondary Point of Contact:
David Fitton,
Contract Specialist
[log in to unmask]<mailto:[log in to unmask]>
Phone: 301-443-5239
Fax: 301-402-3676

https://www.fbo.gov/index?s=opportunity&mode=form&id=33e1a9673e0fe9705b20498c52933ceb&tab=core&_cview=0